SPG Blocks for Headaches
Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department
1 other identifier
interventional
84
1 country
1
Brief Summary
This will be a single-center, open-label clinical trial comparing sphenopalatine ganglion blocks to standard intravenous therapy for patients who come to the emergency department for a headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 3, 2020
September 1, 2020
1.3 years
February 3, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients with Substantial Pain Reduction at 15 minutes
The percentage of patients whose 100 mm visual analog scale pain score reduced by at least 50% from before treatment until 15 minutes after the start of treatment.
15 minutes
Secondary Outcomes (4)
Change in Mean Pain Score at 15 minutes
15 minutes
Change in Mean Pain Score at 30 minutes
30 minutes
Headache 24-72 hours later
24-72 hours
Hospital Length of Stay
30 minutes to 1 week
Study Arms (2)
SPG Block
EXPERIMENTALSphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.
Standard Treatment
ACTIVE COMPARATORIntravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.
Interventions
A cotton-tipped applicator soaked in 1% lidocaine will be inserted into the nostril on the side of the headache. If the headache is bilateral, two cotton-tipped applicators will be inserted. The cotton-tipped applicators will be left in place for 15 minutes.
Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.
Eligibility Criteria
You may qualify if:
- Any patient at least 18 years old who presented to the ED with a suspected primary headache.
You may not qualify if:
- pregnant women
- prisoners
- meningeal signs
- fever
- any acute abnormality on neurologic exam
- allergy to one of study drugs
- on oral anticoagulant
- already received analgesic treatment in the ED
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kendall Healthcare Group, Ltd.lead
- Nova Southeastern Universitycollaborator
Study Sites (1)
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Related Publications (7)
Yarnitsky D, Goor-Aryeh I, Bajwa ZH, Ransil BI, Cutrer FM, Sottile A, Burstein R. 2003 Wolff Award: Possible parasympathetic contributions to peripheral and central sensitization during migraine. Headache. 2003 Jul-Aug;43(7):704-14. doi: 10.1046/j.1526-4610.2003.03127.x.
PMID: 12890124RESULTMaizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x.
PMID: 11279969RESULTBlanda M, Rench T, Gerson LW, Weigand JV. Intranasal lidocaine for the treatment of migraine headache: a randomized, controlled trial. Acad Emerg Med. 2001 Apr;8(4):337-42. doi: 10.1111/j.1553-2712.2001.tb02111.x.
PMID: 11282668RESULTMohammadkarimi N, Jafari M, Mellat A, Kazemi E, Shirali A. Evaluation of efficacy of intra-nasal lidocaine for headache relief in patients refer to emergency department. J Res Med Sci. 2014 Apr;19(4):331-5.
PMID: 25097606RESULTAvcu N, Dogan NO, Pekdemir M, Yaka E, Yilmaz S, Alyesil C, Akalin LE. Intranasal Lidocaine in Acute Treatment of Migraine: A Randomized Controlled Trial. Ann Emerg Med. 2017 Jun;69(6):743-751. doi: 10.1016/j.annemergmed.2016.09.031. Epub 2016 Nov 23.
PMID: 27889366RESULTSchaffer JT, Hunter BR, Ball KM, Weaver CS. Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial. Ann Emerg Med. 2015 May;65(5):503-10. doi: 10.1016/j.annemergmed.2014.12.012. Epub 2015 Jan 7.
PMID: 25577713RESULTMaizels M, Scott B, Cohen W, Chen W. Intranasal lidocaine for treatment of migraine: a randomized, double-blind, controlled trial. JAMA. 1996 Jul 24-31;276(4):319-21.
PMID: 8656545RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Zitek, MD
Kendall Healthcare Group, Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
February 21, 2020
Primary Completion
May 30, 2021
Study Completion
June 1, 2021
Last Updated
September 3, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After completion of data analysis, the data will be available indefinitely.